Agency Information Collection Activities: Submission for OMB Review; Comment Request, 21254-21255 [2024-06439]

Download as PDF 21254 Federal Register / Vol. 89, No. 60 / Wednesday, March 27, 2024 / Notices Board of Governors of the Federal Reserve System. Ann Misback, Secretary of the Board. [FR Doc. 2024–06537 Filed 3–26–24; 8:45 am] BILLING CODE P Board of Governors of the Federal Reserve System. Michele Taylor Fennell, Deputy Associate Secretary of the Board. FEDERAL RESERVE SYSTEM khammond on DSKJM1Z7X2PROD with NOTICES Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company [FR Doc. 2024–06496 Filed 3–26–24; 8:45 am] BILLING CODE P The notificants listed below have applied under the Change in Bank Control Act (Act) (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the applications are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board’s Freedom of Information Office at https://www.federalreserve.gov/foia/ request.htm. Interested persons may express their views in writing on the standards enumerated in paragraph 7 of the Act. Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551–0001, not later than April 11, 2024. A. Federal Reserve Bank of Kansas City (Jeffrey Imgarten, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri, 64198–0001. Comments can also be sent electronically to KCApplicationComments@kc.frb.org: 1. Too Many Investors, LLC and Dallen Jon (D.J.) Hogstad, both of Comanche, Oklahoma; to become members of the Hogstad Control Group, a group acting in concert, to retain voting shares of Commerce Financial Company, and thereby indirectly retain voting shares of Bank of Commerce, both of Duncan, Oklahoma. 2. PBI Trust 35, Thomas S. Dinsdale, as trustee, both of Grand Island, Nebraska; to become members of the Dinsdale Family group, a group acting in concert, to retain voting shares of Pinnacle Bancorp, Inc., Omaha, VerDate Sep<11>2014 17:03 Mar 26, 2024 Jkt 262001 Nebraska, and thereby indirectly retain voting shares of Pinnacle Bank, Lincoln, Nebraska; Pinnacle Bank, Fort Worth, Texas; Pinnacle Bank—Wyoming, Cody, Wyoming; and Bank of Colorado, Fort Collins, Colorado. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10883 and CMS– 10558] Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments on the collection(s) of information must be received by the OMB desk officer by April 26, 2024. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular SUMMARY: PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser: https://www.cms.gov/ Regulations-and-Guidance/Legislation/ PaperworkReductionActof1995/PRAListing. FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: ADA Dental Claim Form; Use: The ADA Dental Claim form and corresponding HIPAAcompliant electronic transaction, known as the 837D, are used widely in the US dental industry to submit claims for health or dental insurance reimbursement. Medicare has traditionally accepted the Professional (CMS–1500/837P transaction) and Institutional (UB04/ 837I transaction) claims to provide payment for Medicare-covered services. The Centers for Medicare & Medicaid Services (CMS) now plans to allow providers to submit Medicare-covered dental services on the dental claim form, a similar information collection as the already-approved professional and institutional claim forms. CMS issued policy clarifications as part of its annual Medicare Physician Fee Schedule (MPFS) Rule that further E:\FR\FM\27MRN1.SGM 27MRN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 89, No. 60 / Wednesday, March 27, 2024 / Notices define when dental services are inextricably linked to a covered medical service. Additional clarifications were included in the CY2024 MPFS final rule. CMS further established a process by which the agency will consider clinical evidence for future policy clarification consideration. CMS anticipates that these regulatory policy clarifications will result in more dental provider participation in the Medicare program. As a result, the Agency’s General Counsel has advised that CMS should begin to accept dental claim formats to remain in compliance with the Health Insurance Portability and Accountability Act (HIPAA) (Pub. L. 104–191). Therefore, CMS through its Part B Medicare Administrative Contractors (MACs) will begin accepting and processing claims submitted by dental providers on the ADA Dental Claim form and HIPAA-standard electronic format equivalent (837D). Form Number: CMS–10883; Frequency: Occasionally; Affected Public: Private Sector, Business or other for-profits; Number of Respondents: 50,000; Total Annual Responses: 50,000; Total Annual Hours: 12,500. (For policy questions regarding this collection contact Charlene Parks at 410–786– 8684). 2. Type of Information Collection Request: Extension of currently approved Information Collection; Title of Information Collection: Machine Readable Data for Provider Network and Prescription Formulary Content for FFM QHPs; Use: Under 45 CFR 156.122(d)(1)(2), 156.230(b), and 156.230(c), as finalized in the rule, the Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2018 (CMS–9934–F), established standards for qualified health plan (QHP) issuers for the submission of provider and formulary data in a machine-readable format to the Department of Health and Human Services (HHS) and for posting the data on issuer websites. These standards provide greater transparency for consumers, including by allowing software developers to access formulary and provider data to create innovative and informative tools. On September 30, 2015, the Office of Management and Budget (OMB) granted approval to the data collection Information Collection for Machine Readable Data for Provider Network and Prescription Formulary Content for FFE QHPs under OMB control number 0938–1284. OMB approval was granted again on November 3, 2017, and March 22, 2021. The Centers for Medicare and Medicaid Services (CMS) is continuing that VerDate Sep<11>2014 17:03 Mar 26, 2024 Jkt 262001 information collection request (ICR) in connection with these machine-readable standards. This ICR serves as a formal request for the renewal of the data collection clearance. The burden estimate for the ICR included in this package reflects the time and effort for QHP and SADP issuers to update and publish the appropriate data and submit it to CMS. No comments were received in response to the 60-day Federal Register notice. Form Number: CMS– 10558 (OMB control number: 0938– 1284); Frequency: Annually; Affected Public: Private Sector, State, Business, and Not-for-Profits; Number of Respondents: 434; Number of Responses: 434; Total Annual Hours: 39,126. (For questions regarding this collection, contact Ana Alza at (667) 290–8569, ext. 70008569). William N. Parham, III, Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2024–06439 Filed 3–26–24; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2002–D–0176 (Formerly Docket No. 2002D–0350)] Handling and Retention of Bioavailability and Bioequivalence Testing Samples; Guidance for Industry (Part Draft, Part Final); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ‘‘Handling and Retention of BA and BE Testing Samples.’’ This guidance is intended to provide recommendations for applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs), including supplemental applications, and contract research organizations (CROs), regarding the procedures for handling reserve samples from relevant bioavailability (BA) and bioequivalence (BE) studies, and recommendations regarding responsibilities of each party involved in the study pertaining to reserve samples. Additionally, this guidance describes the conditions under which the Agency generally does not intend to take enforcement action against an applicant or CRO that retains less than SUMMARY: PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 21255 the quantity of reserve samples specified in the regulation. DATES: Submit either electronic or written comments on the draft portion of this guidance by May 28, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Comments on the final portion of this guidance may be submitted at any time for Agency consideration. You may submit comments on any guidance at any time as follows: ADDRESSES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2002–D–0176 (formerly Docket No. 2002D–0350) for ‘‘Handling and Retention of BA and BE Testing Samples.’’ Received comments will be E:\FR\FM\27MRN1.SGM 27MRN1

Agencies

[Federal Register Volume 89, Number 60 (Wednesday, March 27, 2024)]
[Notices]
[Pages 21254-21255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06439]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10883 and CMS-10558]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of 
information, including each proposed extension or reinstatement of an 
existing collection of information, and to allow a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate or any other aspect of this 
collection of information, including the necessity and utility of the 
proposed information collection for the proper performance of the 
agency's functions, the accuracy of the estimated burden, ways to 
enhance the quality, utility, and clarity of the information to be 
collected, and the use of automated collection techniques or other 
forms of information technology to minimize the information collection 
burden.

DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by April 26, 2024.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, please access 
the CMS PRA website by copying and pasting the following web address 
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. The term ``collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension or reinstatement of an existing collection of 
information, before submitting the collection to OMB for approval. To 
comply with this requirement, CMS is publishing this notice that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: ADA 
Dental Claim Form; Use: The ADA Dental Claim form and corresponding 
HIPAA-compliant electronic transaction, known as the 837D, are used 
widely in the US dental industry to submit claims for health or dental 
insurance reimbursement.
    Medicare has traditionally accepted the Professional (CMS-1500/837P 
transaction) and Institutional (UB04/837I transaction) claims to 
provide payment for Medicare-covered services. The Centers for Medicare 
& Medicaid Services (CMS) now plans to allow providers to submit 
Medicare-covered dental services on the dental claim form, a similar 
information collection as the already-approved professional and 
institutional claim forms.
    CMS issued policy clarifications as part of its annual Medicare 
Physician Fee Schedule (MPFS) Rule that further

[[Page 21255]]

define when dental services are inextricably linked to a covered 
medical service. Additional clarifications were included in the CY2024 
MPFS final rule. CMS further established a process by which the agency 
will consider clinical evidence for future policy clarification 
consideration. CMS anticipates that these regulatory policy 
clarifications will result in more dental provider participation in the 
Medicare program. As a result, the Agency's General Counsel has advised 
that CMS should begin to accept dental claim formats to remain in 
compliance with the Health Insurance Portability and Accountability Act 
(HIPAA) (Pub. L. 104-191). Therefore, CMS through its Part B Medicare 
Administrative Contractors (MACs) will begin accepting and processing 
claims submitted by dental providers on the ADA Dental Claim form and 
HIPAA-standard electronic format equivalent (837D). Form Number: CMS-
10883; Frequency: Occasionally; Affected Public: Private Sector, 
Business or other for-profits; Number of Respondents: 50,000; Total 
Annual Responses: 50,000; Total Annual Hours: 12,500. (For policy 
questions regarding this collection contact Charlene Parks at 410-786-
8684).
    2. Type of Information Collection Request: Extension of currently 
approved Information Collection; Title of Information Collection: 
Machine Readable Data for Provider Network and Prescription Formulary 
Content for FFM QHPs; Use: Under 45 CFR 156.122(d)(1)(2), 156.230(b), 
and 156.230(c), as finalized in the rule, the Patient Protection and 
Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 
2018 (CMS-9934-F), established standards for qualified health plan 
(QHP) issuers for the submission of provider and formulary data in a 
machine-readable format to the Department of Health and Human Services 
(HHS) and for posting the data on issuer websites. These standards 
provide greater transparency for consumers, including by allowing 
software developers to access formulary and provider data to create 
innovative and informative tools. On September 30, 2015, the Office of 
Management and Budget (OMB) granted approval to the data collection 
Information Collection for Machine Readable Data for Provider Network 
and Prescription Formulary Content for FFE QHPs under OMB control 
number 0938-1284. OMB approval was granted again on November 3, 2017, 
and March 22, 2021. The Centers for Medicare and Medicaid Services 
(CMS) is continuing that information collection request (ICR) in 
connection with these machine-readable standards. This ICR serves as a 
formal request for the renewal of the data collection clearance. The 
burden estimate for the ICR included in this package reflects the time 
and effort for QHP and SADP issuers to update and publish the 
appropriate data and submit it to CMS. No comments were received in 
response to the 60-day Federal Register notice. Form Number: CMS-10558 
(OMB control number: 0938-1284); Frequency: Annually; Affected Public: 
Private Sector, State, Business, and Not-for-Profits; Number of 
Respondents: 434; Number of Responses: 434; Total Annual Hours: 39,126. 
(For questions regarding this collection, contact Ana Alza at (667) 
290-8569, ext. 70008569).

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-06439 Filed 3-26-24; 8:45 am]
BILLING CODE 4120-01-P
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